Orange Book product · Brand (NDA)
PROSTIN VR PEDIATRIC
ALPROSTADIL
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
ALPROSTADIL
Strength
0.5MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 018484
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2002CAVERJECT IMPULSEBrand (NDA)
NDA 021212 · PFIZER
- 1997CAVERJECTBrand (NDA)
NDA 020755 · PFIZER
- 1997EDEXBrand (NDA)
NDA 020649 · ENDO OPERATIONS
- 1996MUSEBrand (NDA)
NDA 020700 · VIATRIS
- 1996CAVERJECTBrand (NDA)
NDA 020379 · PFIZER
- 1999ALPROSTADILGeneric (ANDA)
ANDA 075196 · MEITHEAL
- 1998ALPROSTADILGeneric (ANDA)
ANDA 074815 · HIKMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
